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HHS plans for workforce reduction may impact FDA operations

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DC

After months of back and forth and uncertainty related to efforts under the new Trump Administration to reduce the size of the federal government, U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced plans today to significantly decrease the size of HHS, which includes the U.S. Food and Drug Administration (FDA). The planned changes include reducing the HHS workforce by 10,000 full-time employees across various divisions, including an estimated 3,500 from the FDA. These reductions come in addition to the estimated 10,000 employees who have willingly left HHS since the Trump Administration took office. The Administration maintains that essential health services will not be affected.

The stated goals of the plan are to reorganize HHS in an effort to enable more efficient progress on key goals such as reducing the country’s chronic disease burden and cleaning up its food and water supply. Within FDA, drug, medical device, and food reviewers, as well as field inspectors, are reportedly not among those eligible to be terminated under the plan. Nonetheless, this plan would reduce the number of FDA employees by approximately 19%. Although it appears that most of the reductions will be focused on consolidating redundant activities, some industry stakeholders fear a broader impact could hinder important FDA activities, such as policy development (e.g., guidance documents), post-market surveillance activities, and activities in scientific specialty areas such as biocompatibility, human factors, and others. Should these areas be reduced, coupled with additional voluntary departures, there is a potential for an adverse effect on collaboration with industry through programs such as pre-submission and informational meetings, scheduling of fewer advisory committee meetings, longer submission review times, and other downstream effects.

The plan would also centralize functions under HHS such as human resources, information technology (IT), procurement, external affairs, and policy, which are presently handled largely independently by each HHS agency (i.e., FDA, CDC, NIH, CMS). Centralization of communications in particular may be intended, at least in part, to keep tighter control on messaging (e.g., for press releases and safety alerts). These efforts will be accompanied by consolidation of HHS’s 28 divisions into 15 while reducing the number of regional offices from 10 to five.

Because the announcement does not lay out with any degree of specificity the specific groups or organizations within FDA that will be impacted, nor the degree to which any particular group would be reduced, the practical impacts of the plan remain to be seen. We will provide additional updates as they become available.

 

Authored by Janice Hogan, Kristin Zielinski Duggan, Mike Heyl, and Suzanne Levy Friedman.

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